美歐日植物病毒疫苗之商品登記案例研析

Registration of Plant Virus Vaccines: Case Studies from the United States, Europe, and Japan

梁瑩如(Ying-Ru Liang) ； 黃莉欣(Li-Hsin Huang)

《臺灣農藥科學》 10期 (2021/06) Pp. 49-76

https://doi.org/10.6671/TPS.202106_(10).03

摘要

微生物製劑（microbial biological control agents, MBCAs）是指含有微生物的生物農藥，該類藥劑具有控制病蟲害的潛力。隨著我們對微生物防治功效與機制之瞭解，對於微生物製劑的應用層面也隨之擴展，應用輕症病毒株對作物進行交互保護（cross protection）即為一例。本文藉收集整理與探討美國、歐洲、日本已登記之輕症病毒株案例之理化性試驗項目，整理並歸納各國規定，提供我國未來對植物病毒輕症病毒株登記管理之參考。

關鍵字

植物病毒疫苗 ； 登記 ； 法規 ； 歐盟 ； 美國 ； 日本

並列摘要

Microbial biological control agents (MBCAs) are biological pesticides which are derived from microorganisms and have the potential to control plant pests and diseases. As the understanding of MBCA efficacy and the mechanisms which underlie MBCAs has improved, the application of MBCAs has been extended. For example, mild virus strains can now be used to facilitate the cross protection of crops. This study discusses and summarizes the data that is required to register mild virus strains in the United States, Europe, and Japan. Our findings can serve as a reference for the management of mild virus strains in Taiwan.

並列關鍵字

mild virus strain ； registration ； regulation ； European Union (EU) ； USA ； Japan